NCT02117843Unknown不适用
A Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization
Beijing AmsinoMed Medical Device Co., Ltd1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Ischemia-driven target lesion failure(iTLF) , including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
研究概览
简要总结
The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization.
详细描述
The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization, 1200 primary coronary artery disease patients will be enrolled, at approximately 40 sites. Subject follow-up will occur via telephone contact or clinical visit at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 18 years of age;
- •Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI);
- •At least one lesion with a diameter stenosis >70% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5mm to 3.5mm;
- •If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure;
- •Subject has no CABG contraindication;
- •Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF;
排除标准
- •Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure;
- •Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months;
- •Poor compliance or expectation of life less than 1 year;
- •Implanted any brand stent in the same target vessel within 1 year;
- •Left Ventricular Ejection Fraction (LVEF) of <30%;
- •Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support;
- •The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer and contrast agent;
- •Severe tortuous and/or heavy calcification lesion;
- •Two or more proximal chronic total occlusion lesion;
- •Bifurcation lesions with double stents;
- •The subject has multi-vessel lesions but can not be implanted the same brand stents;
- •The subject that the investigator considers he/she was unfit to implant the AVI stents and Firebird 2 stents;
- •The subject attended other drug/device study or in the follow-up period.
结局指标
主要结局
Ischemia-driven target lesion failure(iTLF) , including cardiac death, target vessel related MI(Q wave and Non-Q wave) and ischemic-driven target lesion revascularization(iTLR)
时间窗: at 12 months post procedure
次要结局
未报告次要终点
研究者
研究点 (1)
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